When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to vandetanib, you are pregnant, or you have congenital long QT syndrome.

How to Use This Medicine:
Tablet

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole with water. Do not break, crush, or chew it.
• If you have trouble swallowing the tablets:
  
  • Dissolve the tablet in a glass containing 2 ounces of noncarbonated water. Do not use any other liquid.
  • Stir the mixture for 10 minutes and swallow it right away.
  • Rinse the glass with an additional 4 ounces of noncarbonated water and swallow the mixture to make sure you get the full dose of this medicine.
  • This mixture may also be given through a nasogastric or gastrostomy tube.
• Do not handle tablets that are crushed or broken. Wash your hands or skin with soap and water immediately if you touch crushed or broken tablets.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose and your next dose is due in less than 12 hours, skip the missed dose and take your next dose when you normally do. If your next dose is more than 12 hours away, then take the missed dose as soon as you remember. Take your next dose when your normally do.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Tell your doctor if you are using St John's wort, chloroquine, clarithromycin, digoxin, dolasetron, granisetron, haloperidol, metformin, methadone, moxifloxacin, pimozide, rifampicin, medicine to treat seizures, or heart rhythm medicine (such as amiodarone, disopyramide, dofetilide, procainamide, sotalol).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use effective birth control for at least 4 months after you stop treatment.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, bleeding problems, blood vessel disease, lung disease or breathing problems, underactive thyroid, heart failure, heart rhythm problems (such as QT prolongation or a history of Torsade de pointes), high blood pressure, a history of stroke, or a mineral imbalance (low levels of potassium, magnesium, or calcium). Tell your doctor if you have a recent history of coughing up blood.
• This medicine may cause the following problems:
  
  • Changes in your heart rhythm, such as QT prolongation
  • Serious skin reactions
  • Lung problems
  • Stroke
  • Bleeding problems
  • Heart failure
  • Reversible posterior leukoencephalopathy syndrome (RPLS)
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds. Protect your skin from the sun while you are using this medicine and for 4 months after the last dose.
• This medicine may make you drowsy, tired, or cause blurred vision. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Fast, slow, pounding, or uneven heartbeat
• Headache, seizures, confusion
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Red or dark brown urine, bloody or black, tarry stools, severe diarrhea, unexplained nosebleeds
• Shortness of breath, cough, fever

If you notice these less serious side effects, talk with your doctor:

• Acne, dry skin, severe sunburn
• Change or loss of taste, dry mouth
• Cough, stuffy or runny nose, sore throat
• Diarrhea
• Hair loss
• Nausea, vomiting, stomach pain or upset

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088